Visus Therapeutics, Inc., and Zhaoke Ophthalmology Limited Announce Exclusive Licensing Agreement to Commercialize BRIMOCHOL™ PF and Carbachol PF in Greater China, South Korea and Select Southeast Asian Markets for the Treatment of Presbyopia

mai 11, 2022 Par admin 0
Visus Therapeutics, Inc., and Zhaoke Ophthalmology Limited Announce Exclusive Licensing Agreement to Commercialize BRIMOCHOL™ PF and Carbachol PF in Greater China, South Korea and Select Southeast Asian Markets for the Treatment of Presbyopia

Collaboration expands access to long-acting, presbyopia-correcting eye drops for approximately 600 million patients

Visus to receive upfront payment of $15 million and up to $115 million in potential regulatory and commercial milestone payments, plus tiered royalties on future sales

SEATTLE & HONG KONG–(BUSINESS WIRE)–May 11, 2022–

Visus Therapeutics, Inc. (“Visus”), a clinical-stage pharmaceutical company focused on developing innovative ophthalmic therapies to improve vision for people around the world, and Zhaoke Ophthalmology Limited (“ZKO”), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of treatments that address significant unmet medical needs, today announced an exclusive licensing agreement for the development and commercialization of BRIMOCHOL™ PF and Carbachol PF in Greater China, South Korea and select Southeast Asian territories. BRIMOCHOL PF and Carbachol PF are investigational, preservative-free therapeutics designed to be long-acting, once-daily eye drops to correct for the loss of near vision associated with presbyopia.

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Under the terms of the agreement, ZKO will be responsible for clinical development and regulatory approval for BRIMOCHOL PF and Carbachol PF in the specified territories, and subsequently the commercialization activities for the products. Visus will receive an upfront payment of $15 million and will potentially receive up to $115 million in regulatory, commercialization and sales-driven milestones. Additionally, Visus will earn tiered royalties on future sales of these products in the contracted territories. ZKO will leverage the considerable clinical development experience and plans that Visus has implemented for its currently enrolling Phase 3 studies to fulfill the requisite clinical requirements and bring the products to market quickly.

“We are pleased to partner with Zhaoke Ophthalmology, an innovation-focused company with a highly experienced commercial team and a robust research, clinical and manufacturing infrastructure,” said Ben Bergo, co-founder and chief executive officer at Visus Therapeutics. “Our market research indicates there is high demand for a long-acting, presbyopia-correcting eye drop in China, and we are excited to collaborate with Zhaoke Ophthalmology to accelerate the clinical development and launch our lead candidates in Greater China, South Korea and select Southeast Asian markets.”

“Zhaoke Ophthalmology is excited to join Visus in potentially launching the first once-daily presbyopia-correcting eye drop in Greater China, South Korea and select Southeast Asian markets. After extensive analysis of other presbyopia-correcting eye drops in development, Zhaoke Ophthalmology is confident that BRIMOCHOL PF and Carbachol PF have the potential to become the best-in-class drugs for the treatment of presbyopia, which is backed by the Visus leadership team’s unparalleled experience in the ophthalmology category,” said Dr. Li Xiaoyi (Benjamin), chairman of the board of directors and chief executive officer at Zhaoke Ophthalmology Limited. “We will become the first ophthalmic pharmaceutical company in China with innovative drugs in advanced clinical development covering the three major front of the eye diseases, namely, dry eye, myopia and presbyopia. We will continue to further expand our world-leading pipeline of ophthalmic assets in both the front and back of the eye and advance these promising investigational therapeutics to market in China and beyond as quickly as possible.”

ZKO’s clinical development plans include submitting a new drug application to the Center for Drug Evaluation in China for CsA Ophthalmic Gel for dry eye in the near term, continuing patient recruitment for NVK002 Phase 3 study for myopia, as well as launching the clinical study in China for presbyopia corresponding to the ongoing Phase 3 study of BRIMOCHOL PF and Carbachol PF in the United States.

About Presbyopia

Presbyopia is the loss of near vision associated with aging, making it difficult to perform tasks like reading fine print. It typically begins when adults are in their 40s1 and becomes almost universal by age 50.2 Presbyopia impacts more than 2.1 billion people globally3 with approximately 600 million patients in China, South Korea and Southeast Asia.4 Reading glasses are the most common solution for near-vision correction. However, many people find glasses inconvenient or prefer not to wear them for aesthetic reasons. There are currently no approved presbyopia-correcting therapeutics in China, South Korea or Southeast Asia.

About BRIMOCHOL™ PF and Carbachol PF

BRIMOCHOL™ PF and Carbachol PF are pupil-modulating eye drops designed to be once-daily, preservative-free therapeutics to correct for the loss of near vision associated with presbyopia. BRIMOCHOL PF is a fixed-dose combination of carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). Carbachol PF is a proprietary, preservative-free formulation of carbachol monotherapy. Both investigational therapies reduce the size of the pupil resulting in a “pinhole effect” so that only centrally focused light rays are able to enter the eye, thereby sharpening near and intermediate images. The result is clarity of vision for near tasks like reading or using a smartphone, and intermediate tasks, such as looking at a computer screen. In the VIVID Phase 2 study, both formulations met primary and secondary endpoints, demonstrating a 3-line improvement in near visual acuity with no loss of distance vision out to nine hours.4 BRIMOCHOL PF and Carbachol PF were well tolerated with no serious adverse events. 4 Phase 3 pivotal trials commenced in March 2022, with interim topline data expected in Q4 2022.

About Visus Therapeutics

With offices in Seattle, Wash., and Irvine, Calif., Visus Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative ophthalmic therapies to improve vision for people around the world. The company is developing novel, once-daily, pupil-modulating therapeutics designed to correct the loss of near vision associated with presbyopia. In parallel, Visus Therapeutics is focused on advancing its pipeline of early-stage ophthalmic drug candidates with applications in corneal wound healing, glaucoma and age-related macular degeneration. For more information, visit: www.visustx.com and follow us on LinkedIn, Twitter (@VisusTx) and Instagram.

About Zhaoke Ophthalmology Limited

Founded in 2017, Zhaoke Ophthalmology Limited (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed in the Main Board of the Hong Kong Stock Exchange on 29 April 2021. Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering five major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional CMC and production facilities in Nansha, Guangzhou. For more information, please visit www.zkoph.com.

1 World report on vision. (2019). Retrieved April 29, 2022, from https://www.who.int/docs/default-source/documents/world-vision-report-post-launch-accessible.pdf?sfvrsn=1b29f0e7_2

2 Polat, U., Schor, C., Tong, JL. et al. Training the brain to overcome the effect of aging on the human eye. Sci Rep 2, 278 (2012). https://doi.org/10.1038/srep00278

3 Market Scope, Global Presbyopia-Correcting Surgery Market Report. April 2012.

4 Visus Therapeutics data on file.

Visus Therapeutics:

Media

April Dovorany

April.Dovorany@porternovelli.com

(262) 909-8739

Investor Relations

Paul Sagan

Psagan@lavoiehealthscience.com

(617) 865-0041

Zhaoke Ophthalmology Limited:

Media


Diana Footitt

diana.footitt@artemisassociates.com

(852) 9183-0667

Investor Relations

Jonathan Lee

jonathan.lee@zkoph.com

(852) 2314-5123

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